Senior Associate Quality Assurance (QA) Compliance

Job Description

The Opportunity

Join the CSL Behring Quality Assurance (QA) Compliance team on a full-time 12-month fixed term basis. As the Senior QA Associate, working on site at Broadmeadows, you will co-ordinate self-inspection (internal audits) and regulatory inspection readiness programmes. You will also prepare reports of site quality metric and develop efficiencies for quality data trending and analysis.

The Role

Reporting to the Associate Director, QA Site Compliance Lead, Quality Management, you will participate in the following compliance activities:

• Quality initiatives and taskforces as they arise from various sources and issues;

• Preparation for external inspections and the site’s regulatory inspections and then manage the (CAP) for compliant responses to findings and their closeout;

• Initiate and manage impact assessments of new regulatory requirements;

• Manage all Corrective and Preventive Actions (CAPA) resulting from the Regulatory Alert impact assessments and provide reports as part of the Quality Management Review Process;

• Manage Annual Product Quality Review programs.

Your skills and experience

To be considered for this role you have:

• A degree in science or engineering or pharmaceutical science;

• 3+ years’ experience in the pharmaceutical manufacturing industry in a cGxP environment;

• Experience with cGxP regulatory requirements including industry guidance documents such as those required by TGA or FDA;

• Experience working with information databases and reporting;

• Experience in extracting, analysing and reporting quality data and metrics using Power BI and Excel (can maintain complex spreadsheets);

• Experience leading a technical team in a regulated environment and providing technical support;

• Experience preparing written technical documents and presenting complex information;

• Experience in a role requiring conceptual and analytical thinking to reconcile ambiguities.

How to Apply:

Please apply with your resume and covering letter, which must address the selection criteria above, and include the reference number R-200501 by April 11, 2023

About Us

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.